The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue® (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents. (E-mail: [email protected]). © 2006 World Federation for Ultrasound in Medicine & Biology.
The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations / Piscaglia, F., Bolondi, L., Aiani, L., Luigi Angeli, M., Arienti, V., Barozzi, L., Basilico, R., Bertolotto, M., Biasini, E., Busilacchi, P., Calliada, F., Caremani, M., Caturelli, E., Celli, N., Colecchia, A., Cova, L., Assunta Cova, M., Crocetti, L., De Sio, I., Drudi, F., et al.. - In: ULTRASOUND IN MEDICINE AND BIOLOGY. - ISSN 0301-5629. - 32:9(2006), pp. 1369-1375. [10.1016/j.ultrasmedbio.2006.05.031]
The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations
Barozzi L.;Colecchia A.;Crocetti L.;Gaiani S.;Meloni F.;Sacerdoti D.;Vitali F.
2006
Abstract
The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue® (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents. (E-mail: [email protected]). © 2006 World Federation for Ultrasound in Medicine & Biology.
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